Torii Pharmaceutical Files NDA in Japan for Verrica's TO-208 to Treat Molluscum Contagiosum

WEST CHESTER, Pa., Dec. 06, 2024 – Verrica Pharmaceuticals Inc. has announced a significant development concerning its skin disease treatment. The Company's partner, Torii Pharmaceutical Co. Ltd., has submitted a New Drug Application (NDA) for TO-208 in Japan. This drug, known as VP-102 and marketed under the name YCANTH® in the United States, is intended for the treatment of molluscum contagiosum.

Jayson Rieger, President and CEO of Verrica, highlighted the importance of this development. He praised Torii as an excellent partner in advancing TO-208 and emphasized the submission of the NDA as a crucial step towards introducing the first treatment for molluscum in Japan. Molluscum contagiosum is a common skin disease affecting an estimated 1.6 million people in Japan. Rieger expressed confidence in Torii’s expertise and commercial resources in dermatology to meet this substantial unmet need.

TO-208 features cantharidin as its active ingredient. The Phase 3 clinical trial conducted in Japan, involving patients aged two years and older with molluscum contagiosum, showed that TO-208 was superior to the vehicle in terms of efficacy. Additionally, the safety profile of TO-208 was consistent with previous studies conducted in the U.S., with no tolerability issues observed.

Verrica and Torii have been collaborating on TO-208 since March 2021, when they signed an exclusive license agreement for the drug’s development and commercialization in Japan. In July 2023, Verrica obtained approval in the U.S. to manufacture and market VP-102 for treating molluscum contagiosum. The product has been sold under the brand name YCANTH® in the U.S. since August 2023. Verrica has also completed Phase 2 clinical trials for VP-102 aimed at treating common and external genital warts in the U.S.

YCANTH® is a unique combination product consisting of a carefully formulated cantharidin delivered through a single-use applicator, ensuring precise and targeted application. This product is the first and only FDA-approved treatment for molluscum contagiosum in both adults and children aged two years and above in the U.S. The approval was based on successful results from two Phase 3 trials involving around 500 patients, establishing YCANTH® as a safe and effective treatment for molluscum. YCANTH® is accessible to nearly 228 million individuals covered by insurance, with the treatment priced at $25 per application. Additional financial aid is available for those in need.

Verrica Pharmaceuticals Inc. is dedicated to developing therapies for skin diseases that require medical interventions. Their flagship product, YCANTH® (VP-102), is the first FDA-approved treatment for molluscum contagiosum, a highly contagious viral skin infection affecting about six million people in the U.S., mainly children. The company is also working on VP-103, another cantharidin-based candidate for treating plantar warts. Additionally, Verrica has a global license agreement with Lytix Biopharma AS to develop and commercialize VP-315 for non-melanoma skin cancers, including basal cell carcinoma and squamous cell carcinoma.